Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis

Phase 2TerminatedNCT04252625

University of Utah10 enrolled

Overview

This study will assess the difference in prostatitis symptoms in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo.

This is a Phase 2, double-blinded, placebo-controlled trial assessing the safety of Q-Urol use after brachytherapy placement in patients with localized prostate cancer. Patients will be randomized in a 1:1 ratio to receive Q-Urol/Placebo twice daily for 6 weeks after brachytherapy placement. Questionnaires will be administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Prostate Adenocarcinoma

Interventions

Q-UrolDRUG

Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.

PlaceboDRUG

placebo capsule

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male subjects aged ≥ 18 years. * Men with histologically proven localized prostate adenocarcinoma, stage I - III (as defined by American Joint Committee on Cancer (AJCC) 8th edition), who have selected treatment with brachytherapy with or without external beam radiation, with or without androgen deprivation therapy. * Fluent in speaking and reading English. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. * Adequate organ function as defined as: * Hepatic: * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) * aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN * Renal: * Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula: * Males: ((140-age)×weight\[kg\])/(serum creatinine \[mg/dL\]×72) * Highly effective contraception for both male and their female partners of childbearing potential throughout the study and for at least 5 days after last study treatment administration if the risk of conception exists. * Median life expectancy ≥ 5 years as calculated by the Lee and Schonberg Index (https://eprognosis.ucsf.edu/leeschonberg.php) * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Baseline AUA symptom scores \> 15. * Prior diagnosis of chronic prostatitis type II through IV. * Subject has received systemic therapy intended for the treatment of prostatitis (including herbal supplements) ≤ 14 days of starting study treatment. * Subject has received a fluoroquinolone antibiotic (e.g. ciprofloxacin, norfloxacin, ofloxacin levofloxacin, etc.) ≤ 3 days of starting study treatment. * Subject is actively on anti-inflammatory medications for other medical conditions, unless approved by PI. * Subject has undergone transurethral resection of the prostate (TURP). * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. * History of irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and interstitial cystitis-bladder pain syndrome (IC/BPS). * History of symptomatic hypotension, falls, or syncope * History of hypoglycemia. * Actively abusing alcohol or drugs * Subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Congestive heart failure * Diabetes * Pulmonary artery hypertension * Any clinically significant condition that requires therapy with diuretic medications for any indication other than the management of hypertension. * Other clinically significant disorders that would, in the opinion of the treating investigator, preclude safe study participation. * Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3). * Known allergy to pineapple or pineapple containing products. * Subjects taking prohibited medications as described in Section 7.3 A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.

Locations (2)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)

This outcome will report the mean score of the NIH-CPSI, a 13-item questionnaire. This questionnaire will report 4 sub-scores, Pain, Urinary Symptoms, Quality of Life (QOL) Impact, and Pain + Urinary score, and the total score. Pain: The sum of 6 items (0 No-1 Yes), one scale (0 Never-5 Always), and one scale (0 No Pain-10 Pain as bad as you can imagine); Range: 0-21, higher values indicating worse outcomes. Urinary Symptoms: The sum of 2 urine items (0 Not at all-5 Almost always); Range: 0-10, higher values indicating worse outcomes. QOL Impact: The sum of 2 items (0 None-3 A lot) and 1 scale (0 Delighted-6 Terrible); Range: 0-12, higher values indicating worse outcomes. Pain and Urinary sub-score: The sum of the Pan and Urinary Symptoms scores; Range: 0-31, higher values indicating worse outcomes. Total Score: The sum of all questions; Range: 0-43, higher values indicating worse outcomes. This outcome measure is assessed at 6 weeks after the start of study treatment.

Time frame: up to 6 weeks after the start of study treatment

Secondary Outcomes

The Expanded Prostate Cancer Index Composite (EPIC) Assessment

Health Related Quality of Life (HRQOL) will be assessed with EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate four subscale scores (Urinary Summary, Bowel Summary, Sexual Summary, Hormonal Summary). A higher score (max 100) represents better HRQOL, and a lower score (min 0) represents worse HRQOL.

Time frame: up to 6 weeks after the start of study treatment

The International Prostate Symptom Score (I-PSS) Assessment

Health Related Quality of Life (HRQOL) will be assessed with International Prostate Symptom Score (I-PSS). This is a questionnaire with 7 questions concerning urinary symptoms (from 0 to 5). A high score (max 35) indicates worse HRQOL and a low score (min 0) represents a better HRQOL. These score are reported as Mild (0-7), moderate (8-19) or Severe (20-35). total score ranges from 0 to 35 (asymptomatic to very symptomatic).

Time frame: up to 6 weeks after the start of study treatment

Data from ClinicalTrials.gov

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